JP3001301B2 - A portable device that senses heart function and automatically performs electrotherapy - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates generally to treating human body defects, particularly cardiac defects, by electrotherapy. More specifically, the present invention relates to systems and means for protecting patients susceptible or at risk from sudden death due to heartbeats that are too fast or too slow.

[0002]

BACKGROUND OF THE INVENTION Over the past several years, techniques have been used to correct for too slow a heartbeat (bradycardia) with an implantable device, commonly referred to as a pacemaker. This device applies microjoule electrical pulses to a slowly beating heart to accelerate the heartbeat to an acceptable level. High energy shock (180-360 joules) via an external spatula applied to the chest wall to correct for too slow heartbeats and to prevent fatal consequences of ventricular fibrillation or specific ventricular tachycardia Is also well known. Bradycardia, ventricular fibrillation, and ventricular tachycardia are all electrical arrhythmias of the heart (arrhythmias), and if not corrected by appropriate electrical stimulation, can each lead to death within minutes.

[0003] Since there is a possibility that the electrotherapy device is death and delayed for correction, implantation of pacemaker and defibrillator is greatly improved, treating conditions that could result in threatening these life The ability to do has been enhanced. Implanted in the patient's body, the device continuously monitors the patient's heart in preparation for an arrhythmia to be treated, and when such symptoms are detected, directs electrical pulses for correction directly to the heart. Is applied.

[0004] Pacemakers and defibrillators, which apply an external corrective electrical pulse to the patient's chest wall, have also been used to correct such life-threatening arrhythmias, but have been associated with acute arrhythmias. So far it has drawbacks, as it may not be possible to save the patient's life by preparing the device in time of an emergency. Such treatment must be effective within minutes. Thus, if the patient is at high risk of death due to such arrhythmias, implant the electrical device for immediate use when treatment is needed. Alternatively, such patients are housed in a hospital where electrotherapy for correction is readily available. However, prolonged hospitalization is often not feasible due to its high cost and the need for patients to engage in routine activities.

[0005] There are also many patients who are prone to cardiac arrhythmias and who are temporarily at risk of sudden death. For example, patients suffering from coronary artery occlusion and myocardial infarction are at significant risk of developing tachycardia for several weeks after coronary artery occlusion. Such patients are generally hospitalized, but can be discharged early if there are practical ways to save life from life-threatening arrhythmias.
There are also many patients who are waiting for an implantable defibrillator, and such people can use external defibrillation that can be on hand in case of a life-threatening tachyarrhythmia. Need a container. In addition, some patients require an implantable defibrillator and are at a transient risk due to the surgery required to implant such a device.

From the foregoing, it is clear that patients susceptible to electrical cardiac upset do not need to undergo an implantation procedure and do not need to remain in the hospital, resulting in a relatively long term Clearly, there is a real need to provide effective means that can be protected.

[0007]

SUMMARY OF THE INVENTION It is an object of the present invention to ensure that patients prone to certain cardiac arrhythmias do not need to undergo an implantation procedure and remain in the hospital and are effectively protected from the adverse consequences resulting therefrom. Can be done. It is to provide a system and means as described above. Another object of the present invention is
It is an object of the present invention to provide an externally administered electrotherapy in an effective form that does not require the patient to abstain from normal daily activities and can protect the patient from the consequences of cardiac arrhythmias for a relatively long time.

It is a further object of the present invention to allow a patient to wear comfortably over a relatively long period of time, to detect a condition to be treated within the patient, and to provide electrotherapy to the patient in response thereto. It is an object of the present invention to provide a treatment apparatus applicable to any of the above. The present invention is a system and means by which an arrhythmia-prone patient can be substantially protected from death therefrom, which can be comfortably worn and yet nevertheless provide the patient with a potentially fatal arrhythmia. A patient-mounted portable external pacemaker with the ability to continuously monitor and to quickly and properly apply electrical pulses for correction in the event of such arrhythmias
Systems and means are provided that include a defibrillator. The present invention also provides non-patient-worn systems and means that support the most efficient use of the versatility and reliability of operating a patient-worn device. The system and means of the present invention make the best use of reliable operation and, furthermore, make the device as comfortable and user-friendly as possible to allow the patient to wear such a device as far as possible. The emphasis is on

Further, the present invention provides a number of means by which a patient at risk can comfortably wear an automatic external pacemaker / defibrillator. Among them are means for minimizing the weight of the device, means for distributing the weight-bearing surface over a large area of the body, means for wearing the device loosely in standby mode, and between the device and the skin of the patient. There are means for comfortable placement of underwear. Most importantly, the device also includes means for creating a low impedance path for the electrical pulse to travel to the heart when a potentially dangerous arrhythmia is detected by the device.

[0010] Accurate and positive detection of arrhythmia with high reliability and minimal false detection are important to the usefulness of wearable antiarrhythmic devices. Accordingly, the device also preferably continuously monitors one or more physiological indicators of the arrhythmia to be treated. Detects patients so that they can learn behavior patterns that make the most effective use of reliable device operation, as the various behaviors of the patient can lead to unreliable detection results. Means for advising the state of the circuit may be provided. The device may also include means by which the patient may delay the application of the high energy shock if the patient is conscious and the arrhythmia is not yet shown to be life threatening.

[0011] It is a further object of the present invention to provide different types of system monitoring means that maximize the safety, efficacy and reliability of a patient-worn device. Such monitoring means includes means for checking the operational readiness of the patient-worn device, means for checking the battery status of the device,
Means for recharging the battery as necessary, means for recording the contents of the memory of the patient-worn device, and transmission of life-related data to a remote healthcare manager for advice on problem solving and proper operation of the device Means may be included.

The above objects and other objects which will become apparent hereinafter, as well as the nature of the present invention, will be more clearly understood by reference to the following description, the appended claims and the accompanying drawings.

[0013]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Briefly, in a preferred form of the invention as illustrated in the drawings,
Automatic electric heart therapy device worn by the patient, for example device 10 shown in general view in FIG. 11 or device 200 shown in general view in FIGS. 14 and 15 , and each therapy device 10 or 200 is not used on the patient At times, a maintenance subsystem or module 12 is provided, shown generally in FIG. 13 , which can be mounted thereon to effectively maintain, program and charge it.

As shown in FIG. 11 , in a first embodiment, the patient-worn device is a belt 14 wrapped around a waist made of a suitable cloth, band, or the like, and includes a low-profile connector or buckle 16. A belt, which may be elastic or include a spring element, and a shoulder strap 18 of similar material connected between the front and back of the belt. The first and second sensing and pulse electrode assemblies 20 are respectively connected to the belt 14.
And a shoulder strap 18.
The belt 14 also includes a pulse transmitter 24, which receives an electrical signal from each electrode assembly 20 as well as a support strap 26 that connects to the strap 18 and emits electrical pulses to that assembly. For this purpose, it has conductors shown by reference numerals 28 and 30. Both assemblies 20 each have a sensing electrode 22 and a pulse electrode 32.

In use of the apparatus as described above, the assembly 20 is held in comfortable contact with the patient's chest wall and continuously monitors and detects cardiac rhythm by means of each sensing electrode 22. Alternatively, a conventional disposable ECG electrode may be used as the sensing electrode, and may be disposed on the patient's skin at a location away from the pulse electrode 32.
If the sensing electrodes detect a cardiac arrhythmia to be treated, these electrodes send a sensing signal to the pulse generator via electrical conductors 28 and 30 and in response the pulse generator generates an appropriate therapy pulse for each pulse. Reply to the pulse electrode 32. In addition, each electrode assembly further includes means (described below) for automatically reducing the impedance in applying electricity to the heart when an appropriate signal indicating the start of treatment is received from the pulse generator. Such impedance reducing means include, for example, means for automatically tightening each pulse electrode 32 against the patient's skin and means for automatically releasing the conductive electrode gel to the electrode-skin interface.

Returning to FIG. 11 , it is understood that the device 10 can also be worn over a comfortable undergarment 34, such as a T-shirt, having an opening 36 for receiving each electrode assembly 20. Attachment 38, for example, a patch cloth of loop pile type magic tape (Velcro type),
It may be provided between the underwear and the belt 14 and the strap 18. FIGS. 2A and 2B show each sensing electrode 22 in detail. Each centrally located sensing electrode in each assembly 20 comprises a cylindrical plastic housing 40 into which an interior chamber 42 fits, which is comprised of an EGG electrode 44 and an associated amplifier 46. And a voice converter, that is, a microphone 48. The EGG electrode 44 may be capacitive conductive carbon or any structure that can be used for a long period of time without causing discomfort to the skin. The microphone is acoustically connected to port 50, which carries audio energy to a vibrating version of the microphone. The diameter of the inner chamber is usually about 2.
5 cm . Above the amplifier 46 and the microphone 48, a flexible printed circuit 52 is provided and electrically connected thereto, for supplying power to the amplifier and the microphone and receiving signals therefrom. The printed circuit of each electrode is shown in Fig. 1.
It is understood that is connected to a pulse generator 24 via a conductor 28 and 30 were referenced with respect to 1.

The inner chamber 42 fits into the outer chamber 40 and is a pad 5 of synthetic foam foam located under the chamber cover 60.
4 applies pressure on the inner chamber and thus on the skin surface to ensure constant contact between the ECG electrode surface and the skin at all times when the system is worn. 3 to 5 show the overall appearance and dimensions of each electrode assembly 20 and show the sensing electrodes 22 disposed inside the pulse electrodes 32. FIG. The electrode assemblies are each composed of a mobile composite
It has an outer housing 56 with a skin contact area of cm ² .

[0018] FIGS. 6-9 show the interior of the electrode assembly housing has been removed. Each sensing electrode 22 fits into the center of each pulse electrode, and a recess 58 is provided on the upper surface of the central chamber cover 60. The recess 58 includes a motorized release or trigger mechanism consisting of a heating coil of resistance wire 62 wrapped around a synthetic fiber activation member 64. The member 64 has a headed end 65 which holds two spring loaded balancing rods in place, such that a spring 68 exerts a force on the rods so that the two It moves through the individual cantilever tubes 70. Included within tube 70 is a synthetic fabric tension member 72, one end of which is secured to washer 74 and the other end (not shown) of which may be belt 14 or strap 18 as appropriate. Inside the structure. Thus, as the balancing rod moves through the tube, the tension member 72 is pulled through the tube, thanks to being attached to the washer,
Tension is applied to the end of the belt 14 or strap 18 that secures each electrode housing, thereby tightening the electrode assembly against the patient's skin and providing a robust form of impedance reduction.

Between both tubes 70, on each side of the electrode body, a capsule 76 containing a conductive fluid such as an electrolyte gel is mounted facing the groove of the central housing 40. The central part of the balancing rod 66 surrounds the gel capsule,
As a result, the bar, when activated, moves along the capsule to compress the capsule and push the gel toward the end of the electrode assembly away from the central housing 40. An elongated port 82 at the outer end of the capsule 76 communicates with a groove 80 in a substrate member 84 of the electrode body. FIG. 9 is a bottom view of the electrode assembly, showing a state in which the gel groove 80 extends radially from the capsule port 82. FIG. 10 shows the skin contact surface from a cross section. Although the gel grooves are open along the length, the substrate member 84 is covered by a flow restricting plate 86, which has a restricted opening 88 communicating with each groove.

Although the dimensions of the gel channels are such that there is little impediment to the flow of the conductive gel over the entire length of the gel channels, the openings 88 do somewhat impede the flow of the gel.
This difference in resistance to flow causes the conductive gel to quickly fill all of the grooves when the extrusion mechanism is activated, and then slowly extrude the gel through the holes in the flow restrictor. After passing through the flow restriction plate, the gel infiltrates the pulsed electrode plate 90 of wire mesh or perforated foil, and the electrode plate may be paced, cardioverted or defibrillated, or electrotherapy. Carry the necessary current to. As the gel wets the metal member, the impedance at the interface is significantly reduced, and a second form of impedance reduction is provided, thereby increasing the electrical connection to the skin.

In a dry, non-operating condition, a comfortably soft and absorbent cloth 92 covers the electrode plate 90 and is in contact with the patient's skin. Usually this cloth is cotton. The cloth may be sewn to the surface of the electrode, or may be gently snapped over the electrode in a state where the edge of the cloth wraps around the edge of the electrode and is pulled by the elastic member. In this latter form, it is possible to maintain the cleanliness by frequently changing the cloth surface.

FIGS. 12 (a) and 12 (b) show a belt mechanism 9 that can be used to sense breathing motion.
4 is shown. A strain gauge 96 is joined to a metal backing plate 98, which is securely attached to the belt 14. A molded cover 100 is applied over the gauge element for protection, which also encloses the conductor 102.
The operation of the system will now be described with particular reference to FIG.

A set of sensors (monitoring means) is used to collect information about the patient's symptoms. The monitoring means includes a respiration sensor 94 as described above for detecting chest wall movement, a microphone 48 for picking up heart sounds or breathing sounds, an ECG electrode 22 for monitoring a surface electrocardiogram, and a "normal" potential for the electrode 22. Reference ECG electrode 106
(Known per se). The signal from the sensor is amplified and conditioned by each amplifier 108, 110, 112 and signal processing network 114. The adjusted signal is sent to the microprocessor 116.

The microprocessor has a system memory 1
18 in conjunction with a patient monitor, clocking and back grayed La <br/> und all functions required for operation, recording of arrhythmias and system events, communication with the maintenance subsystem 12, the treatment sequence, the system and the electrode Performs a self-test of the function and monitoring of status switches 120 and 122. The microprocessor and memory, and together constitute the essential elements of the pulse oscillator 24 as described with respect to FIG. These components are known per se in cardiac treatment devices and will not be described in further detail.

The system memory 118 also contains tests and conditions for declaring the event to be treated. When an event to be treated is sensed, the microprocessor initiates the treatment as programmed in system memory. The mode and sequence of treatment can be set individually for each patient and can include low or high energy cardioversion / defibrillation as well as a wide range of pacing treatments.

When the event to be treated is sensed, the microprocessor activates the pressurizing means 124 (ie, the release mechanism 62 described above), which causes the pulse electrode 32 to be firmly against the patient's chest wall. attract. At the same time, the electrode gel 126 is released by the treatment electrode as described above, resulting in a low resistance contact. An impedance sensing circuit 128 is incorporated into the system to establish that a low resistance condition exists. At this point, the microprocessor will operate the speech synthesizer 1 to obtain a fault free state.
A verbal alert may be issued via 30 and speaker 132 to initiate either pacing by pacing circuit 134 or high energy shock treatment by defibrillation circuit 136 via the pulsed electrode. The patient can, by his choice, delay the treatment by pressing the two "live man" switches 120 simultaneously. Thereafter, treatment begins when the patient loses consciousness and releases the switch. Otherwise treatment is delayed.

Other functions that can be included in the system are charged by plugging into the RF communication link to the maintenance system via receiver / transmitter 140 and antenna 142 and into the charging port 148 of the maintenance system. A power source 144 that may have a rechargeable battery pack 146. Sensor (switch 12
2) may be "attached" to the patient to inform the microprocessor that the device is located on the patient. A self-inspection function may be incorporated. For example, "l
The patient can initiate a test program by pressing one of the "live man" switches, which reports the status of the device and / or any fault condition through the speaker 132.

The maintenance subsystem 12, shown in a block diagram on the right side of FIG. 1, includes a microprocessor-based support device for the belt device 10. The main function of the maintenance subsystem is to provide a charger 150 for the belt power source 144 as well as a communication link, for example, between the belt and a telephone line. Charging can be accomplished by using the built-in charging coil 152 when the belt is over the maintenance device 12, or by extending the coil if the patient is wearing the belt for remote use. It can be implemented by any of the following. Alternatively, charging may be performed by alternately using two battery packs. Communication with the belt is performed via the RF link 156 and the antenna 158. Communication with the telephone line is made via a dialer-equipped modem 159 and a built-in speakerphone 160.

Next, other possible functions of the maintenance system will be described. In FIG. 1, reference numeral 162 denotes a microprocessor with a system memory. This microprocessor controls all system functions. It also serves as a system clock with a time and status display display 164. The system memory is preferably large in capacity as compared to the belt memory and capable of storing more of the patient's electrocardiogram and other data. The belt memory is periodically "dumped" into a maintenance system, where it is stored and finally prepared for relay to a physician via telephone.

The maintenance system also serves as a belt testing system. For this purpose, the test electrode output terminal 166 (FIG. 13 ) is positioned so that the ECG test electrode is close to the belt pickup electrode when the sensor 168 determines that the belt is on the maintenance system. Similarly, respiratory transducer 170 and microphone test transducer 154 are located near their corresponding sensors.
This allows a complete functional test of the belt sensing and detection mechanism by using the test circuit 162 (FIG. 1). This test can be performed automatically or can be initiated by the patient using the test button 174.

The maintenance system may be one that obtains electric power from an AC power line or one that includes a backup battery 176 in case of a power failure. Other features include a power and charge status lamp 178, a button 180 in an emergency to dial a physician or other remote medical facility with a single push of a button, and enable telephone diagnosis and treatment in an emergency. There is a built-in speakerphone 182 for convenience. A compartment 184 for storing the charging coil may be provided.

By adapting the monitoring means, the Q of the patient's heart
The RS electrical depolarization may be detected, and the heartbeat of the patient may be measured from the QRS detection interval. In addition, the rate of change of the patient's heart rate can be monitored. Alternatively or alternatively, utilizing the presence of the aortic valve closing sound, Q
The sensing of the RS electrical complex may be proved or substituted. A tachycardia to be treated is declared when the patient's heart rate exceeds the set value for a predetermined period of time and the change in heart rate exceeds the set level. If the patient's heart rate falls below the set rate for a predetermined period, it is declared a bradycardia to be treated. In addition, gasping or breathing may be used as a detection parameter to apply a high energy defibrillation shock, or a fast heartbeat and / or heartbeat may be used to indicate the need to apply a high energy defibrillation shock. It may be used in combination with acceleration.

As shown in FIGS. 14 and 15 , a second embodiment of a heart treatment device 200 having a function similar to that of the first embodiment of the device 10 includes a comfortable vest shaped upper body garment structure 202. Can be worn. As explained below, the garment structure may be one that fits the body shape, has elasticity, and ensures sufficient contact between the sensing transducer and the skin surface. This vest is configured with a sewable pocket 204. This pocket is provided with a sliding fastener 206 or other actively acting closure means, into which the electrode assembly 208 of the device 200 is inserted before use by the patient. A pulse generator 210 of the device is mounted on the vest, and a conductive system 212 extends between each electrode assembly and the pulse generator. The device 200 is in the form of a self-contained treatment package in which the electrical conductors are housed in a suitable sheath 214 or the like, which connects the various subassemblies. This device also
It may include a respiration sensor 216. This configuration allows for a large number of vests to be prepared and kept clean, allowing quick and easy exchange of treatment packages between the vests, ensuring relatively uninterrupted sensing and treatment. .

The vest may be further provided with a reinforcement at an appropriate position. The stiffener converts the movement of the upper half of each electrode housing into a radial pressure on the patient's skin upon receiving a therapy start signal from the pulse generator. As in the previous embodiment, the vest may have an opening that allows each electrode assembly to contact the patient's skin. In addition, the vest may have attachment means at its lower edge for attaching itself to a belt, lower body garment, or the like.

The two ECG sensing / pulsing electrode assemblies 208 each include an ECG sensing electrode 218 (FIG. 1 ).
6 (b)). The electrode is located in a cylindrical plastic housing 220, which is
It is located in the center of each assembly 208. The electrode housing 220 houses a flexible sensing electrode 218 filled with conductive fibers, two motion sensing elements 222, 224, and an associated amplifier 226. Sensing electrode 218
Can move freely within the housing in the vertical direction, but its movable range is limited by the molding bosses 228, 230. A spring 232 located below the chamber cover exerts pressure on the sensing electrodes and thus on the patient's skin surface, ensuring constant contact between the ECG electrode surface and the skin at all times when the system is worn.

[0036] Each electrode assembly 208 further should described (see FIGS. 17 to 19) the upper plate 234, housing cover 236, compression plate 238,2 pieces of the U-shaped fluid storage chamber 240,2 amino It comprises a bladder or bag 242 containing a conductive fluid, a compression spring 244, two puncturing mechanisms 246, and a voltage controlled thermally activated release mechanism. The chamber is permanently affixed to a housing cover having a folding tab 248. A compression plate 238 is provided under the housing cover 236 and a movable bladder or bag 24 containing electrolyte or similar conductive fluid is provided between the pressure plate and the bottom of the chamber.
2 is located.

The plates 234 and 238 are held close to each other by a thermally actuated release mechanism. This mechanism includes a cylindrical release sleeve 262, a torsion spring 264 located in a groove 278 around the upper end of the release sleeve, a resistance wire heating element 266, and a synthetic fiber restraining member 268 ( FIG. 2 ) .
4 (a) and FIG. 24 (b) ). Member 268
Is a perforated tab 27 having one end formed on the upper plate 234.
The other end is fixed to the deformed part of the torsion spring 272. Insulating strip 27
4 is provided below the heating element to isolate the heating element from the top plate and to provide a means for making an electrical connection to this element.

The flange 276 at the lower end of the release sleeve engages the lower surface of the compression plate 238 and the groove 278 at the upper end of the sleeve.
Engage with the torsion spring 264. The spring (when compressed) engages the upper side of the upper plate. After detecting the condition of the heart to be treated and receiving the appropriate signal from the pulse generator 210, the heating element 266 melts and punctures the restraining member 268, releasing the free end of the torsion spring 264, and Is released from the groove of the release sleeve and releases the upper plate.

The compression spring 244 exerts pressure on the top plate 234 and moves it upward (away from the skin), carrying with it the upper half of the electrode housing 260 secured to the top plate. This movement, through the enclosed pocket 204 of the vest structure and the reinforcement sewn into the vest,
Radial pressure is transmitted to the chest wall, reducing the electrode-skin interface impedance and ensuring sufficient compression for effective pulse application.

In addition, the compression spring 244 exerts downward pressure on the compression plate 238 and the release sleeve 262, which can move freely toward the skin. This downward pressure is transmitted to the bladder 242 containing the fluid. The piercing mechanism includes a pointed member 250 attached to the compression plate, which moves through each holding tube 252 and pierces the bottom surface of the fluid container when both plates 234 and 238 are pulled apart. As the compression plate moves within its possible range, the fluid medium is forced out of the sac and into the ports 256 and grooves 254 located at the bottom portion of the electrode assembly, by these means to the pulse electrode 258 and the patient's skin surface. It is carried and reduces the impedance by infiltrating this interface.

It will be apparent that an electrode structure similar to structure 208 may also be used in a belt-type garment including a belt, such as belt 14 and / or a shoulder strap, such as strap 18, as described above. In yet another form of the invention, the impedance reduction mechanism may include a hydraulically actuated mechanism for increasing compression of the pulse electrode against the patient's skin in response to detecting a cardiac condition to be treated. it can. Such a hydraulically actuated mechanism comprises a belt or strap carrying the electrodes, such as the belt 14 or strap 1 described above.
A gas cartridge for tightening 8 can be included.

One such embodiment is a gas supply (pressurized cylinder) 310 (FIG. 25 ), as well as located on or near the pulse generator package 210, which is under pressure when the gas supply is activated. Consists of an electrically actuated actuator or squib 312 with a conduit 314 for carrying the same gas to each electrode housing 316. Such a second embodiment comprises a local gas supply 318 and an actuator 320 located within each electrode housing, as shown in FIGS. 27 (b) and 27 (c).

In any of such embodiments,
Each electrode may have an inflatable cell or bladder 322 (FIGS. 26 and 27 ) that expands and moves in two directions when activated. Upon detection, an electrical signal is transmitted to the gas actuator to release gas from each gas supply and pressurize the inflatable cell.

The resistive heater 324, which is held near the lower wall 326 of the fluid bladder 328 by a thermally bonded membrane 330 or other attachment means, heats up when activated to melt the bladder wall and membrane and to pit. Is opened, thereby releasing the electrolyte fluid or gel from the capsule. The pressure applied by the inflated cell causes fluid to squeeze out of the bladder and into port 332 and groove 334 as in the previous embodiment,
The treatment electrode 336 in contact with the skin and the skin surface are infiltrated.

The movement of the cell due to expansion is also transmitted to the upper half 338 of the housing of the electrode assembly, moving it upwardly away from the skin. This movement through the enclosed pocket 204 of the vest structure and the reinforcement sewn into the vest or garment transmits radial pressure against the chest wall and reduces the impedance of the electrode-skin interface.

A known volume controlled gas supply, which can check inflatability or bladder integrity by demonstrating pressure maintenance after a pilot gas inflation by a monitoring system, can be used for monitoring. Base station. The structure of the vest / wearing band is designed to allow enough space for comfortable wearing for a long time. The structure should be sized before day-to-day wear to ensure that this clearance is less than the combined expansion distance of the electrodes, and to obtain sufficient compression for effective pulse transmission. to be certain.

[0047] FIGS. 28 to 53, focusing on patient comfort and is designed to be able to hide as much as possible under the usual street clothes, shows therapeutic system according electrotherapy. Referring to FIG. 28 , a patient-worn cardiac arrhythmia correction system includes an electronics package 400 (typically equivalent to the pulse generator 24 of the previous embodiment) mounted on the patient's left thigh, and an electronics package; Consisting of an interconnected flexible printed circuit conductive system or optional flat cable 402 extending between the annular belt and electrode assembly 404 mounted further around the chest.

The shoulder belt 406 includes a telescoping portion 408 (FIG. 37 ) that applies a static tension thereto and is connected to and supports the annular belt 404. Integrated Belt / Holster 410 Wrap Below Waist or Buttocks
Supports the electronics package at the position of the left thigh and further includes leg straps 412
May be included.

Referring to FIG. 29 , in a fourth embodiment, the package 400 and the hip belt 410 are
It has been replaced by an articulated or segmented electronics package 414. This package is worn under the patient's right chest or waist and carried on a belt 416 wrapped around the waist and also attached to the shoulder belt 406 via yoke 418, thereby attaching the electronics package. Support from the position of the chest.

The chest belt 404 carries a detection or sensing electrode structure 422 for detecting the condition to be treated in the patient, along with a treatment electrode structure 420 for administering electrotherapy when the condition to be treated is detected. . These structures are described in further detail below. The belt also carries a reading device 424 in tether. FIG. 28 to FIG. 41
The annular chest belt 404 of the form shown in FIG. 7 is mainly composed of polymer closed-cell foams of various densities and thicknesses.
This structure, the pressure on the sensing and treatment electrodes belt is supported on the maximum limit, selectively load or pressure to minimize the pressure on the area that do not implement the electrical function of the metal or nonmetal added to skin spring It may include a member.

Referring to FIG. 30 , an elastic member or layer 426 is applied to the chest belt over substantially the entire circumference thereof. The elastic member 428 in FIG. 31 is applied only to the right front quadrant of the patient. In FIG. 32 , the belt has a stack of polymeric foam configured as a folded structure 430 with sensing electrodes 422 contained therein and isolated from one another to form the inner circumference of the belt, and the Are embedded in the layers to form the outer periphery of the belt. Hooks 434 and loop pile type fasteners 436 or other means are provided on the mating surfaces of the folds to keep the assembly intact. A stretchable member 438 is applied between the inner and outer perimeters around the entire circumference of the belt and attached to the sensing area by another hook and loop pile type fastener 440, thereby applying local compression to that area. with added, it is removed the member easily in preparation for cleaning and by Ru can Unishi.

Referring to FIG. 36 , a dry, electrocardiographic sensing electrode 422 is integrated into an annular chest belt, each electrode being arranged in a biaxial manner along the circumference of the belt. It is associated with a buffer amplifier that enables ECG sensing as well as a high band reference electrode 442. Similarly, what is integral with the chest belt, a reading unit 424 in FIG. 28 (not shown in FIG. 36). This means has a pocket clip or similar fastener in its housing and either a tether cable 402 from the computer in the electronics package to the display means 444 in the readout device or, optionally, via a wireless link. It allows a visual message to be sent to the patient. Device 424 may include means such as a confirmation switch 446 for the patient to respond and confirm receipt of the message. The readout device controls the beginning of treatment and the patient operates the switch in response to stimulation by the device (FIG. 5 ).
4 See (a)) to start a treatment if the patient does not respond.
In the embodiment using a tether cable, the readout device and the attached cable are attached from the chest belt through the garment to a pocket or the like so that the patient can easily see and respond. An embodiment without a tether cable utilizing a wireless link may be worn anywhere on the body desired by the patient. Similarly what is integrated into the chest belt are means to attach the interconnecting cable between the conductors 432 of the electronics package and electrical conductors, for example, FIGS. 32 and 34. As shown in FIG. 39 , the conductor 448 may be configured as a flexible printed circuit or, optionally, as a flat cable interconnecting the various electrodes on the belt 404.

Similarly, what is integrated with the chest belt is molded members 450a and 450b having elasticity (FIG. 3 ).
9 to FIG. 41 ). These members are curved to concentrate the circumferential force exerted by the belt on the sensing electrodes and to move the portion of the belt between the electrodes away from the skin to increase comfort during wear. Also integrated into the chest belt is a means that allows the perimeter of the chest belt to be adjusted at the point of use to the patient's chest circumference. For example, the curved elastic members 450a and 450b are interrupted over the patient's back and are perforated in a pattern that allows coarse adjustment of the length by changing the distance of the overlap. Molded snap rivets 45
2 (FIGS. 38 (a) -38 (c)) or other similar anchoring means disposed in the aperture 454 of the mating portion actively locks the member to the desired length for easy release. No means is obtained. Thus, this adjustment will apply an appropriate amount of tension to the annular belt and, as a result, will apply a moderate amount of pressure to the sensing and treatment electrodes.

The treatment electrode 420 is approximately 11 × 6.4 cm in size and is electrically and mechanically attached to an annular chest belt at the left front of the patient. Similar treatment electrode 420
a is approximately 17 × 9 cm in size and is electrically and mechanically attached to the chest belt and shoulder belt at the portion of the patient's back that is to the right of the center and above the axis of the chest belt. With this positioning, the center of the site of the treatment electrode will be located on an axis passing through the heart. These electrodes, as in the previous embodiment,
The system is configured to apply therapeutic energy to the heart when an arrhythmia to be treated is detected, and to reduce the electrode-skin impedance before applying the energy. The electronic aspects of these electrodes are generally well known in the art, and the present invention is particularly concerned with the structural aspects of the electrodes and the means for reducing impedance. The impedance reducing means mainly consists of a means for pushing a highly conductive fluid between the treatment electrode surface and the patient's skin.

Referring to FIGS. 43-50, the front treatment electrode 420 is comprised of multiple layers of various elastic materials (the configuration of the rear treatment electrode is substantially the same). The outermost layer 460 (located just below the underside of the belt 404) is typically polycarbonate or a similar plastic, which adds strength and shape to its structure. Underneath is a layer of microporous and elastic closed cell foam or similar material 462. This layer is configured to provide flexibility to the assembly and, as shown in cross-section,
Formed as a cavity 464 to provide protection for layers further inside the electrode structure described below. Another larger cavity 466 is formed in the foam layer of the anterior treatment electrode and integrated into the belt structure, the tactile stimulator 468.
Accepts housing. This device is a small electric motor and has an eccentric weight 470 mounted on its shaft. The motor is configured to be powered for a short time by a signal from a computer in the electronics package. When the motor is powered , it causes the abdominal skin to vibrate and the tethered readout device 424
Call attention to the patient to respond to the message displayed in.

The inner layer of the treatment electrode further includes an outer conductive fluid containing layer 472, an inner fluid containing layer 474, a sealing layer 476 peelably welded to the surface of the inner fluid layer, and a conductive layer. Includes a high treatment electrode layer 478. A soft, porous, replaceable cloth material 480 is sandwiched between the treatment electrode layer and the patient's skin. Layers 472 and 474 are typically elastic thin films exhibiting low water vapor transmission rates and are thermoformed to define blister portions 482 having a shape similar to a half cylinder. Due to the differences in the dimensions of the formed blisters, the blisters of layer 474 can fit tightly inside the blisters of layer 472. A weld 484 is applied to a portion of the periphery of the contained blister except for the area 486. This area consists of shallow thermoformed grooves interconnecting all pairs of blisters in the treatment electrode. These grooves ultimately contain a larger blister pair 488 containing an electrically operated gas source 490.
Connect to

At the time of manufacture, the blisters formed in the inner storage layer 474 are filled with the conductive fluid 492, and then sealed while using a V-shaped welding shape 494 as shown in FIG. Layer 476 is welded and placed. The internal components of the gas source are heat conductive pressure chamber 502
Gas generation cartridge 496 that fits inside
Also, a porous plug of hot filtration media 498 that fits tightly within the opposite end of the pressure chamber. This end of the chamber is also fitted with a small diameter orifice 500. The structure of this description is based on the larger blister 4
A circumferential object welded into 88.

When an arrhythmia event to be treated is detected,
An electrical signal is sent to the gas generating cartridge, which ignites a chemical pellet in the cartridge consisting of lead styphnate and a gas generating mixture of ammonium dichromate and nitroguanidine, which rapidly decomposes and releases nitrogen gas. appear. This gas breaks the rupturable membrane 504 at the end of the gas generator housing and creates a pressure chamber 50.
Passed through 2. This gas is then cooled by propagating to the walls of the pressure chamber, filtered as it passes through the filtration media 498 and orifice 500, restricted, and cooled, and then into the larger blister pair 488. Passed.

From this larger blister section, the gas is forced into the gas groove 486 by expansion and welded into the electrode stack, creating a volume between the two overlapping thermoformed blister sections 472 and 474. Apply pressure. As the pressure increases, the mating but not welded surfaces of the blister portions 472 and 474 are pulled apart, and the inner blister portion 474 is inverted into the conductive fluid. The force on the fluid exerts hydraulic pressure on the sealing layer membrane 476 at the lower surface of the assembly, creating a destructive V-shaped weld 49.
4 (see FIG. 47 ) is peeled off, and port 5 in layer 476 is removed.
The fluid is extruded through 06 and carries the fluid over the treatment electrode layer 478 in contact with the skin and into the small space between this layer and the skin surface. To do this, the layer 478
May be porous or may be formed to have a suitable fluid opening.

This fluid wets the interface, including the sandwiched fabric, thereby reducing its impedance. In addition to the means for reducing impedance using conductive fluid,
Further reduction means may include spring-loaded means for increasing the pressure of the treatment electrode against the patient's skin in response to detection of a cardiac condition to be treated. The mainspring 508 (FIG. 4) is released by a signal from the electronics package at the same time as the signal to activate the gas generator.
2 ) applies a rotational force to the two drums 510 and 512 having different diameters. A metallic or non-metallic pull member, as described with respect to the previous embodiment, is wrapped around the outer periphery of the drum and passed through grooves formed or formed in the outer cover of the chest belt structure. Since this member is pulled when the spring is activated, it exerts an additional 0.5 to 6 pounds of pulling force on both belts, the annular belt and the shoulder belt. Such an increase in tension on the belt greatly increases the compression of the electrode against the skin, resulting in a further reduction in impedance.

FIGS. 52 (a) -52 (c) show one embodiment of a segmented breast mounted therapy package 414. FIG. The electronics package is a molded shell 514
a, 514b and 514c, respectively.
It is divided into segments 414a, 414b and 414c. The storage shell has a radius of 516 and fits snugly into the body's curvature, ensuring comfortable long-term wear. Additionally, the housing shell, shaped so as to draw a complicated curve in the vertical plane and the horizontal surface, the curvature of the chest shown in curved or FIGS. 29 to 35 of the thigh shown in 512 of FIG. 51 (b) Any one of them may be adapted.

In this embodiment, a conventional printed wiring board 5
20 and the interconnections between the segments are made of conventional flat string conductors 522. A flexible and resilient gasket 524 provides a perimeter seal to the conductor and segment interface. Alternatively, as shown in FIGS. 53 (a) and 53 (b), a “rigid printed circuit board 526 is laminated on various areas of a rigid printed circuit board 528 including the effective components of the device. The electronics system may be constructed using a "flex" structure.

Although only the preferred embodiments of the present invention have been described in detail herein, the present invention is not limited thereto but can be modified within the scope of the appended claims.

[Brief description of the drawings]

FIG. 1 is a block diagram illustrating a first embodiment of a wearable automatic pacemaker / defibrillator device and functional components of a maintenance subsystem of the device.

FIG. 2 (a) is a cross-sectional elevation view of a first embodiment of an integrated ECG electrode / heart sound microphone used with a pacemaker / defibrillator for heartbeat detection. (B) It is a bottom plan view of a microphone.

FIG. 3 is a plan view illustrating a first embodiment of a sensing and pulse electrode assembly used in a defibrillator.

FIG. 4 is a side view of the electrode assembly.

FIG. 5 is an end view of the electrode assembly.

FIG. 6 is a partially cutaway enlarged plan view showing the inside of the electrode assembly, with its cover removed.

FIG. 7 is an end view of one of the electrode components.

FIG. 8 is a side view of the electrode assembly, with its cover removed.

FIG. 9 is a bottom plan view of the electrode assembly, with its cover partially removed.

FIG. 10 is an exploded elevation view of each part of the electrode assembly.

FIG. 11 is a view of use of a first embodiment of a pacemaker / defibrillator, with the patient wearing it.

FIG. 12 (a) is a plan view of a respiration sensor used in a first embodiment of a pacemaker / defibrillator. (B) It is an elevation view of a respiration sensor.

FIG. 13 is a perspective view of a maintenance subsystem.

FIG. 14 is a view of use of a pacemaker / defibrillator according to a second embodiment of the present invention, with the upper body garment worn thereon.

FIG. 15 shows the second embodiment of the pacemaker / defibrillator in somewhat more detail in an in-use arrangement.

FIG. 16 (a) is a plan sectional view of a sensing electrode assembly used in a second embodiment of the present device. (B) A sectional elevation view of the sensing electrode assembly used in the second embodiment of the device.

FIG. 17 is a sectional elevation view of the pulse electrode assembly used in the second embodiment of the device, showing the assembly in a standby mode.

FIG. 18 is a sectional elevation view of a pulsed electrode assembly used in a second embodiment of the device, showing the assembly in an operating mode.

FIG. 19 is an enlarged elevational sectional view showing components of the pulse electrode assembly in a standby mode.

FIG. 20 is an enlarged elevational sectional view showing components of the pulse electrode assembly in a standby mode.

FIG. 21 is an enlarged sectional view showing each part of the pulse electrode assembly in a standby mode.

FIG. 22 (a) is a diagram showing each part of the puncture structure in the operation mode. (B) It is a figure which shows each component of the puncture structure in an operation mode. (C) It is a figure which shows each component of the puncture structure in an operation mode. (D) is a diagram showing each component in a standby mode. (E) is a diagram showing each part in the standby mode. (F) It is a figure showing each part in a standby mode.

FIG. 23 is a bottom plan view of a pulse electrode.

FIG. 24 (a) is a plan view of a voltage controlled thermally actuated release mechanism, shown in a standby mode. (B) Plan view of the voltage controlled thermally actuated release mechanism, shown in operating mode.

FIG. 25 is a view of use of a third embodiment of a pacemaker / defibrillator, with the patient wearing it.

FIG. 26 (a) is a plan view of an electrode housing,
It is shown with the gas supply source mounted remotely. (B) An end view of the electrode housing, with the gas supply source mounted separately. (C) A bottom view of the electrode housing, wherein a fluid container,
FIG. 7 shows the resistance heating element and the holding member without the groove. (D) A bottom view of the electrode housing, wherein a fluid container,
It is a figure which shows the resistance heating element and the holding member in the state which arrange | positioned the groove | channel.

FIG. 27 (a) is a plan view of an electrode housing,
The gas supply source is shown as being locally mounted in the pad-like housing. (B) It is an end view of an electrode housing, and shows the gas supply source in the state mounted locally in this pad-shaped housing. (C) An enlarged end view showing the electrode housing including the fluid container, the resistive heating element and the retaining membrane in more detail.

FIG. 28 is a partial view of the use of the third embodiment of the patient-worn cardiac arrhythmia correction system, with the thoracic belt and the treatment package attached to the left thigh.

FIG. 29 is a fragmentary view showing the use of the fourth embodiment of the patient-worn cardiac arrhythmia correction system, with the thoracic belt and the treatment package mounted below the right chest.

FIG. 30 is a use view showing the front part of a chest belt of the type shown in FIGS. 28 and 29, in a state in which an elastic member is arranged over the entire circumference thereof.

FIG. 31 is a use view showing the front part of the chest belt, showing a state in which the elastic member is applied only to the left front quadrant of the patient.

FIG. 32 is an illustration of the use of a further embodiment of a chest belt, wherein the conductive system is embedded in the outer circumference of the belt, the sensing electrode structure is integrated with the discontinuous inner circumference of the belt, and the elastic pulling means is the outer circumference. It is shown in a state of being sandwiched between the inner periphery and the inner periphery.

FIG. 33 is an enlarged view showing an electrode portion of the belt structure shown in FIG. 32.

FIG. 34 is an enlarged view showing an electrode portion of the belt structure shown in FIG. 32.

FIG. 35 is an enlarged view showing an electrode portion of the belt structure shown in FIG.

FIG. 36 is a plan view of the body surrounding structure shown in FIGS. 28 and 29, where the upper chest belt is shown in cross section when viewed from above the patient.

FIG. 37 is a partial rear view showing the use of the third and fourth embodiments of the chest belt / electrode structure.

FIG. 38 (a) is a bottom plan view of the belt adjustment lock device. (B) It is a side view of the adjustment locking device of a belt. (C) It is a use figure of the adjustment locking device of a belt.

FIG. 39 is an enlarged detail view of a portion near the rear treatment electrode of the belt, showing the belt adjusting means.

FIG. 40 is a view similar to FIG. 39, showing the flexible conductive system overlying the adjustment means;

FIG. 41 is an exploded view of a curved elastic member forming an adjusting means.

FIG. 42 (a) is a front view and a side view showing a tensioning device operated by a mainspring. (B) It is the front view and side view which show the tension | spring device of a mainspring spring actuation type.

FIG. 43 is a perspective view of a front treatment electrode.

FIG. 44 is a plan view of a partially cut bottom portion of the front treatment electrode.

FIG. 45 is an elevational sectional view of the anterior treatment electrode as seen from line 26-26 of FIG. 44.

FIG. 46 is an enlarged sectional view showing a part of the front electrode before use.

FIG. 47 is a view similar to FIG. 46, but showing a state in which fluid is released from the electrodes.

FIG. 48 is a sectional view taken along line 29-29 in FIG. 45;

FIG. 49 is a sectional view taken along line 30-30 in FIG. 45;

FIG. 50 is a perspective view showing one layer of the front electrode structure.

FIG. 51 (a) is an end view of a treatment package mounted on a leg. (B) It is a top view of the treatment package attached to a leg.

FIG. 52 (a) is a plan view (partially cut away) showing an embodiment of a segmented treatment package worn on the chest. (B) Front view showing one embodiment of a segmented treatment package to be worn on the chest. (C) End view showing one embodiment of a segmented treatment package that is worn on the chest.

FIG. 53 (a) is a cutaway plan view showing each embodiment of the breast-mounted package. (B) It is a notch top view which shows each embodiment of a breast | wearing type package.

FIG. 54 (a) is a block diagram showing each operation mode of the treatment apparatus shown above. (B) It is a block diagram which shows each operation mode of the treatment apparatus shown previously.

──────────────────────────────────────────────────続 き Continuation of the front page (72) Inventor Larry D. Bowling United States of America Pennsylvania 15238 Pittsburgh Fieldcrab Broad 937 (72) Inventor Joseph F. Rashial United States of America 15235 Pittsburgh Hollywood Drive, Pennsylvania 2508 (56) References JP-A-1-320069 (JP, A) US Patent 4,928,690 (US, A) (58) Fields studied (Int. Cl. ⁷ , DB name) ) A61N 1/36

Claims (16)

(57) [Claims] 1. An electrode assembly for applying electrotherapy to a patient's body when a condition to be treated occurs, said electrode assembly having a conductive surface disposed adjacent to the patient's skin. Electrode means for applying to the patient, contained within said electrode means and contained in at least one flexible fluid bladder in the assembly, releasing between the conductive surface of said electrode means and the patient's skin Impedance-reducing means that includes a conductive fluid to be applied and that is sent to the patient's skin by the electrode means when the condition to be treated is detected and reduces the impedance between the conductive surface of the electrode means and the patient's skin. Pressurizing means for squeezing the flexible fluid bladder; and the flexible fluid bladder in response to the operation of the pressurizing means for sending a fluid under pressure from the flexible fluid bladder to the conductive surface. Connections that provide connections between conductive surfaces Includes a stage, wherein the connecting means comprises a sealed conduit means extending between said flexible fluid sac and said conductive surface, said conduit means,
An electrode assembly characterized in that it is forcibly opened by a pressure acting on itself from the fluid of said flexible fluid sac in response to actuation of a pressurizing means. 2. The method of claim 1, wherein the conduit means comprises a sheet of material that also defines a bladder.
The assembly of claim 1, wherein the assembly is defined between laminations. 3. A pouch comprising a third layer of sheet material stacked on one of the two laminates and defining a gas pressurization chamber above the pouch, wherein the pressurizing means is for squeezing the pouch. 3. The assembly of claim 2 including means for supplying a gas under pressure to said chamber. 4. A means for defining a gas pressurized chamber on at least a portion of the outer surface of the bladder, wherein the pressurizing means includes means for supplying gas under pressure to the chamber to squeeze the bladder. Item 2. The assembly according to Item 1. 5. A bladder is defined between two stacks of sheet material, and a pressure chamber is defined between one of the layers and a third layer of sheet material stacked thereon. The assembly of claim 4. 6. A sealed, sealed means defined between the two laminates and forcibly opened by pressurized fluid from the bladder in response to actuation of the pressurizing means. 5. The assembly of claim 4 including a conduit means. 7. A pressurized chamber and conduit means are folded over the area of the stack, one of the stacks and the third stack to connect each chamber to a common source of pressurized gas. An assembly according to claim 6, wherein a groove is defined between 8. The pressurizing means defines a chamber around at least a portion of the bladder for receiving gas under pressure to squeeze the bladder; a source of pressurized gas; The assembly of claim 1, including means for moving between the source and the chamber. 9. The assembly of claim 8, wherein the source of gas under pressure comprises a cartridge in the assembly, wherein the cartridge comprises an electrically activated gas generating chemical. 10. An electrode assembly for delivering electrotherapy to a patient's body when a condition to be treated occurs, the electrode assembly being disposed adjacent to the patient's skin for applying an appropriate electrical pulse to the patient. A layer of conductive material provided; a first sheet of flexible material disposed on the conductive material; laminated on the first sheet, and combined therewith;
(a) at least one fluid storage bladder, (b) conduit means for connecting the bladder with the layer of conductive material, and (c) a frangible seal between the bladder and the conduit means. A second lamella of flexible material defining; squeezing said bursa defining said at least one chamber laminated on said second lamella and at least partially surrounding said bursa; Containing gas within the bladder under pressure effective to break the seal by pressurizing the fluid therein, such that fluid from the bladder passes through the conduit means to a layer of conductive material. A second sheet of flexible material that reduces impedance between the layer and the patient's skin by allowing access to the gas under pressure when the condition to be treated is detected. And gas supply means for supplying gas to the chamber. 11. The assembly according to claim 10 , wherein the bladder, conduit means, frangible seal and chamber fold over a common area of the lamella, and gas supply means is connected to each chamber. 12. The assembly according to claim 11 , further comprising a passage means connecting at least two of the chambers defined between the second and third lamellas for supplying gas between the chambers. 13. The second and third lamellae each having a mating bulge and defining the chamber therebetween, the second lamella being combined with the area of the first lamella. 11. The assembly of claim 10, wherein said fluid containment sac is formed. 14. A gas supply means is defined between the second and third lamellas and a compartment in the assembly containing the electrically activated gas generating chemistry. 11. The assembly of claim 10 including passage means for connecting to the chamber. 15. The assembly of claim 10 , including a compartment including a tactile stimulator for applying a mechanical stimulus to the patient's skin in response to the received signal. 16. The assembly of claim 15 , wherein the stimulator comprises an electric motor having an eccentric weight mounted on the shaft.